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Design Transfer
We prepare your validated design for production. Working alongside your manufacturing partner, or our own Build team, we transfer design intent into the documentation, tooling, and processes needed to produce it as verified.
Please feel out the form below and someone from our team will contact you shortly.
Phase Overview
Design Transfer is where a validated design becomes a manufacturable product. Specifications become device master record content and work instructions, production tooling is specified and qualified, and processes are established through installation, operational, and performance qualification. We support this work as the design authority, defining requirements, reviewing protocols, and confirming that what gets built matches what was verified. Execution sits with the manufacturing partner, whether that's our own Build team or a manufacturer you've already selected.
What Happens in This Phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that turn a validated design into a qualified production process.
Production Documentation
Device master record content and work instruction requirements defined for your manufacturing partner to implement.
Tooling & Fixtures
Tooling and fixture requirements specified, with designs reviewed and qualification criteria established.
Process Development
Critical process parameters identified from the design, with manufacturing requirements documented for development.
Process Qualification
IQ, OQ, and PQ protocols reviewed against design requirements, with results assessed for conformance.
Inspection & Test Methods
Inspection criteria and test methods defined from design specifications for validation in production.
Supply Chain Qualification
Material and component specifications provided, with supplier qualification supported against design requirements.
Training & Readiness
Design intent transferred to production teams, with readiness reviewed before first production build.
Risk Management
Design risk file updated as process risks are identified, with controls reviewed for design conformance.
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What You Walk Away With
A design ready to produce and a partner ready to produce it: device master record content and work instruction requirements, specified and qualified tooling, reviewed IQ, OQ, and PQ documentation, defined inspection and test methods, supported supplier qualification, and trained production teams. A first production build that conforms to the verified design.
Why This Phase Matters
A design that only one team can build isn't transferred, it's borrowed. This phase is where knowledge moves out of the development team and into documentation, tooling, and trained people, so the device can be produced without the people who designed it, whether that partner is our own Build team or a manufacturer you've already selected. A thorough transfer produces a process that scales predictably and survives turnover. An incomplete one leaves production dependent on undocumented knowledge and the individuals who hold it.
Commercial Phases
You can engage with us in any phase of your design and development from concept generation to design transfer. Return to the full view to find the best place to get started.
Please feel out the form below and someone from our team will contact you shortly.
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